Osteoporosis is a devastating condition in all population at all ages. The prevalence rate increases with age. Generally, the porous bones become thin, brittle, and easily broken, especially at carpus, femur, and vertebrae. The most apparent syndromes of osteoporosis are vertebral compressive fractures that lead to back pain, shortening of height, and kyphosis. The bone mineral density (BMD) peaks at 35 to 40 years old in human. Women at age 50 during menopause lose bone mineral at the rate of 1 to 3% yearly and the bones become porous. The prevalence of osteoporosis in women is twice that of men.
The action mechanism of currently available therapeutics, for examples, bisphosphonates, specific estrogen receptor modulator, calcitonin, and estrogen, are mostly inhibiting the activity of osteoclasts. Parathyroid hormone is the only one that is working on stimulation of osteoblasts. There are many undesirable side effects and their long-term safety are not clear. Unfortunately, osteoporotic patients need to take these medications in a very long term. Among these medications, calcitonin and parathyroid hormones are peptide in nature. They need to be administered by daily injections or inhale that are not user-friendly to the patients.
The worldwide trend on natural modality of health care on osteoporosis is limited to high calcium diet of milk, dairy products, fishes, soy and deep green leaves, and weight-bearing exercises. The prior arts have taught some natural foods or herbs that had effects on prevention or treatment of osteoporosis. For examples, Diane Feskanich reported that women took one serving of lettuce per day had 45% less chance to get femur fracture than women took less than one serving per week. The authors suggested that vitamin K in lettuce was the active component (Am. J. Clin. Nutr. 69: 74-79, 1999). The present invention comprises seeds of lettuce, and the preparation does not contain vitamin K. L. Cui. Y. F. Ma reported that oral gavage of water extract of Epimedium sagittatum maxim, Astragalus mimbranaecus, and Rhizoma attractylodis macrocephalae at 1.0 g/Kg to ovariectomized rats was able to prevent mineral loss and increase bone mass (J. Bone and Mineral Res. 14 (Suppl 1): S283, 1999). The herbal composition of the present invention is different from the aforementioned disclosures, and the present invention shows better effect on the increase in BMD than the aforementioned disclosures.
Hu X. disclosed in China patent number CN1099294 in 1995, that powder containing Gypsum Fibrosum, Cinnamomi Ramulus, Citri Tankan Exocarpium, Ephedrae Herba, Paeoniae Radix, Ponciri Trifoliatae Fructus, Rhizoma Chuanxiong, Poria, Moutan Cortex, Rhizoma Pinelliae, Rhizoma Atractylodis Macrocephalae, Magnoliae Cortex, Scutellariae Radix, Citri Reticulatae Pericarpium, Perillae Fructus, Codonopsis Pilosulae Radix, Angelicae Sinensis Radix, Bupleuri Radix, Aconiti Lateralis Preparata Radix, Semen Juglandis showed activities of anti-inflammation in bone marrow and treated osteomyelitis and hyperosteogeny. However, the composition of this 20 herbs containing preparation was different from the composition of the present invention, and the claim of the aforementioned disclosure was for anti-inflammatory activity, not for preventing and treating bone fracture and osteoporosis as the present invention. Lui, H. disclosed in China patent number CN1079160 in 1993, that powder containing Aquilariae Resinatum Lignum, Flos Carthami, Aucklandiae Radix, Rhizoma Chuanxiong, Cinnamomi Ramulus, Eupolyphaga Seu Steleophaga, Rhizoma Drynariae, Semen Strychni, Achyranthis Bidentatae Radix, Semen Cucumis, Herba Abri, Rhizoma Rhei, Pyritum, Borneolum and Sanguis Draconi improved the function of kidney, and was able to treat the defects in bone and cartilage development. However, the composition of this 18 herbs containing preparation was different from the composition of the present invention, and this disclosure did not present any well controlled study to support its efficacy on curing bone fracture and osteoporosis. Masuko Shiyouji et. al. disclosed in Japan patent number JP4266820 in 1992, that carbon number 22 to 38 long chain saturated alcohol was able to prevent bone mineral loss and promote bone formation; however, in the aforementioned patent, the composition was extracted and purified from wheat germ oil or rice bran oil by alcohol, that was different from the present invention. The present invention comprises seeds of Fructus Oryzae without the bran, not of wheat germ oil or rice bran oil. Other prior arts, with compositions different from the present invention, such as China patent number CN1195697, CN1266696, CN1180530, CN1287853, CN1181958, CN1071843, CN1219428, CN1245711, CN1312096, CN1113440, CN1083727 and CN1277848, claimed for their usefulness in treating bone fracture based on Chinese medicinal theories without experimental data or well controlled studies to support the effectiveness of their claims. The present invention with composition different from all of the aforementioned patents and publications demonstrates its efficacies on preventing and treating bone fracture and osteoporosis by both in vitro and in vivo studies. The present invention provides a new composition from a herbal combination that is able to prevent and treat bone fracture and osteoporosis by a natural therapeutic modality.